DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 6, 13, and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonzalez (US 5,313,939) in view of Hammerton-Fraser (US 4,316,458; hereinafter “Hammerton”) or Singh (US 2010/0163023A1).
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In relation to claim 1, Gonzalez shows in figure 1, a device for targeted delivery of a substance to an airway of a patient [see Gonzalez; abstract], the device comprising: a conduit (1) comprising a proximal end and a distal portion having at least one distal end, wherein the proximal end is configured to be coupled with a source of the substance provided via a mechanical pump [see Gonzalez; column 5, lines 25-26; connector (3) provides the capability for connection to a pump for ventilating or oxygenating the patient’s lungs]; and at least one applicator [see syringe connected to connector (21)] coupled with the at least one distal end of the conduit (17), wherein the at least one applicator is configured to direct the substance out of the at least one applicator toward a portion of the airway of the patient.
In relation to the amendment filed on 10/06/2025, independent claim 1 has been amended to recite the following limitation:
“a flow control device positioned between the mechanical pump and the at least one applicator, wherein the flow control device is configured to control a flow of the substance through the conduit by the mechanical pump.”
This limitation would have been considered conventional in the art at the time of filing in view of the teachings of Hammerton or Singh.
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Hammerton shows in figure 1 above, a flow control device [relief valve (14)] positioned between the mechanical pump (13) and the at least one applicator (19), wherein the flow control device (14) is configured to control a flow of the substance through the conduit by the mechanical pump (13) by controlling the pressure within the conduit.
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Additionally, Singh demonstrates in figure 4B, the conventionality of positioning a flow control device (408) between the mechanical pump (460) and the at least one applicator (462), wherein the flow control device (408) is configured to control a flow of the substance through the conduit by the mechanical pump (460). Based on the teachings of Hammerton or Singh, for an artisan skilled in the art, the use of a flow control device in the apparatus disclosed by Hammerton would have been considered obvious in view of the demonstrated conventionality of this enhancement. Moreover, the artisan would have been motivated to make the modification because the addition of a relief valve would have enhanced the safety standards of the system by preventing over-pressurization within the system.
In relation to claim 4, Gonzalez explicitly discloses in column 1, starting in line 23, “an endotracheal tube is placed through a patient's nose or mouth and down into the trachea (windpipe).” Therefore, if it is placed through the patients nose or mouth, it must rest against a portion of the patient’s mouth.
In relation to claim 6, as discussed above, Gonzalez shows in figure 1, a device wherein the device is configured to be advanced into the airway and used for substance delivery without requiring attachment to any other airway device.
In relation to claim 13, Gonzalez shows in figure 1, a device wherein a conduit comprises part of an endotracheal tube.
In relation to claim 14, Gonzalez shows in figure 1, a device wherein the applicator (19) is configured to remain in the airway while an endotracheal tube is positioned in the airway.
Claims 2, 3, 5, 7-12, and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonzalez (US 5,313,939) in view of Hammerton-Fraser (US 4,316,458; hereinafter “Hammerton”) or Singh (US 2010/0163023A1), as discussed above, and in further view of Goldin et al. (US 4,327,721), Khan et al. (EP 1974766A1), and Holt et al. (US 9,061,097B2; hereinafter “Holt”).
Gonzalez in view of Goldin
In relation to claim 2, Gonzalez does not explicitly disclose a conduit that is configured to removably attach to an endotracheal tube. However, this enhancement would have been considered conventional in the art as evidenced by the teachings of Goldin.
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Goldin discloses a conventional cuffed endotracheal tube is provided with an annular chamber (22) circumferentially extending around the insertion tube in association with the wall thereof between the cuff and the rearward or external end of the insertion tube [see Goldin; figure 3]. Accordingly, for an artisan skilled in the art, modifying the apparatus disclosed by Gonzalez with a conduit capable of attaching to an endotracheal tube, as taught by Goldin, would have been considered obvious in view of the demonstrated conventionality of this enhancement. Moreover, the artisan would have been motivated to make the modification because the addition of the cuff would have facilitated connection of the endotracheal tube with other medical devices.
In relation to claim 7, Gonzalez does not disclose a conduit comprises two conduits joined together along at least part of a proximal portion. However, as discussed above, Goldin discloses two conduits (26, 28) joined together along at least part of a proximal portion. Accordingly, for an artisan skilled in the art, modifying the apparatus disclosed by Gonzalez with a conduit comprising of two conduits, as taught by Goldin, would have been considered obvious in view of the demonstrated conventionality of this enhancement. Moreover, the artisan would have been motivated to make the modification because the addition of the two conduits would have facilitated connection of the endotracheal tube with other medical devices.
In relation to claim 11, Gonzalez does not explicitly disclose an applicator made of a material to allow for slow weeping of a substance. However, Goldin teaches "atomizing means for delivering the topical agent as a spray" [see Goldin; abstract]. Therefore, for an artisan skilled in the art, modifying the apparatus disclosed by Gonzalez with an applicator made of material to allow for slow weeping of a substance, as taught by Goldin, would have been considered obvious in view of the demonstrated conventionality of this enhancement. Moreover, the artisan would have been motivated to make the modification because since atomizing means would have been considered well-known in the art at the time of the invention, the implementation of this enhancement would have been considered an obvious alternative in the design of the delivery device.
In relation to claim 12, Gonzalez does not disclose an attachment member. However, as discussed above, Goldin teaches an attachment system for an endotracheal tube. Therefore, for an artisan skilled in the art, modifying the apparatus disclosed by Gonzalez with an attachment member, as taught by Goldin, would have been considered obvious in view of the demonstrated conventionality of this enhancement. Moreover, the artisan would have been motivated to make the modification because the addition of the attachment member would have facilitated connection of the endotracheal tube with other medical devices.
Gonzalez in view of Khan
In relation to claim 3, Gonzalez does not explicitly disclose a conduit configured to removably attach to a laryngeal mask airway. However, Khan teaches cuffs that can be used with various airway devices including SLT (Single Lumen Tube), Double lumen, Bronchial Blocker, RAE Laser tubes,
Tracheostomy tubes, supra glottic instruments, etc. [see Khan; paragraph 0092]." Therefore, for an artisan skilled in the art, modifying the apparatus disclosed by Gonzalez with a conduit configured to be removably attach to a laryngeal mask airway, as taught by Khan, would have been considered obvious in view of the demonstrated conventionality of this enhancement. Moreover, the artisan would have been motivated to make the modification because a laryngeal mask airway is a type of supra glottic instrument.
In relation to claim 5, as discussed above, Gonzalez teaches the device resting in the patient's mouth. Moreover, it is common knowledge in the medical field that endotracheal tubes placed orally
rest against the patient's teeth. Therefore, for an artisan skilled in the art, it would have been obvious that the device of Gonzalez would rest against the patient's teeth when placed orally.
In relation to claim 8, the examiner notes for the record that the limitations of space within the human body decide the shape and size of implants configured to be placed in the body. Therefore, designing a device with a particular shape and size to fit in a particular area of the body would have been considered an obvious design based on the limitations imposed by the body.
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In relation to claims 9 and 10, Gonzalez shows in figure 1, two applicators (15) configured to contact two sides of the airway. If the apparatus is shaped to conform to the anatomy of the airway [see curved shape of figure 1 above], an artisan skilled in the art would have recognized that modifying the length of the apparatus to reach a desired areas of the body [(a) the glossopharyngeal nerve or the superior laryngeal nerve and (b) posterior tonsillar pillar or a piriform sinus] would have been an obvious design alternative based on desired outcomes.
Gonzalez in view of Holt
In relation to claim 15, as discussed above, Gonzalez discloses an apparatus wherein the proximal end is configured to be coupled with a source of the substance provided via a mechanical pump [see Gonzalez; column 5, lines 25-26; connector (3) provides the capability for connection to a pump for ventilating or oxygenating the patient’s lungs].
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To further demonstrate the conventionality of configuring the proximal end of a curved tube for coupling to an infusion pump, the examiner incorporates Holt into the rejection. Holt shows in figure 1, a curved tube (54) connected to an infusion pump (156). The pump is configured to deliver a volume of the drug to a patient [see Holt; abstract]. Accordingly, for an artisan skilled in the art, modifying the apparatus disclosed by Gonzalez with the capability of connecting to an infusion pump, as taught by Holt, would have been considered obvious in view of the demonstrated conventionality of this enhancement. Moreover, the artisan would have been motivated to make the modification because this capability would have facilitated the accurate infusion of a drug into a patient’s body.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nathan Price can be reached on 571-270-5421. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783